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A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease (FIRST)

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ClinicalTrials.gov Identifier: NCT01052779
Recruitment Status : Completed
First Posted : January 20, 2010
Results First Posted : May 15, 2018
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

January 15, 2010
January 20, 2010
March 26, 2018
May 15, 2018
May 15, 2018
March 1, 2010
July 19, 2011   (Final data collection date for primary outcome measure)
  • Mean Change In Hemoglobin From Baseline (Day 1) To Week 5 [ Time Frame: Baseline (Day 1), Week 5 ]

    The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as:

    Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline)

    The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were performed without imputation for missing data and with the Markov chain Monte Carlo method.

  • Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5 [ Time Frame: Baseline (Day 1) and up to Week 5 ]
    The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug).
To evaluate the safety of IV ferumoxytol compared to IV iron sucrose
Complete list of historical versions of study NCT01052779 on ClinicalTrials.gov Archive Site
Not Provided
To evaluate the efficacy of ferumoxytol as compared to iron sucrose by assessing changes in hemoglobin from Baseline to Week 5 [ Time Frame: 35 days ]
Not Provided
Not Provided
 
A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease
Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease
The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Iron Deficiency
  • Anemia
  • Kidney Disease
  • Drug: Ferumoxytol
    IV Ferumoxytol
    Other Name: Feraheme
  • Drug: Iron Sucrose
    IV Iron Sucrose
    Other Name: Venofer
  • Experimental: Ferumoxytol
    Participants received an IV injection of ferumoxytol (510 milligrams [mg], 17 milliliters [mL]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).
    Intervention: Drug: Ferumoxytol
  • Active Comparator: Iron Sucrose

    Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.

    Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.

    Intervention: Drug: Iron Sucrose

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
150
April 19, 2012
July 19, 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Key Inclusion Criteria include:

  1. Males and females ≥18 years of age
  2. An estimated glomerular filtration rate <60 mL/minute or a diagnosis of CKD (such as nephropathy, nephritis)
  3. Hemoglobin <11.0 g/deciliter (dL)
  4. Transferrin saturation <30%
  5. Hemodialysis participants on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week
  6. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of the study

Exclusion Criteria:

Key Exclusion Criteria include:

  1. History of allergy to IV iron
  2. Allergy to 2 or more classes of drugs
  3. Female participants who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
  4. Hemoglobin ≤7.0 g/dL
  5. Received another investigational agent within 4 weeks prior to screening, or planned receipt of an unspecified investigational agent during the study period
  6. Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12 or folate deficiency)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Germany,   India,   Poland,   United Kingdom,   United States
 
 
NCT01052779
FER-CKD-201
2009-015630-30 ( EudraCT Number )
Yes
Not Provided
Not Provided
AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc.
Not Provided
Not Provided
AMAG Pharmaceuticals, Inc.
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP